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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 Dec - 23 Dec 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EPA OPPTS 879.2700 (draft)
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom, UK

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
444-000-2
EC Name:
-
Cas Number:
647028-25-9
Molecular formula:
This is a UVCB so NA
IUPAC Name:
3-[3-(pentanoyloxy)-2,2-bis[(pentanoyloxy)methyl]propoxy]-2,2-bis[(pentanoyloxy)methyl]propyl pentanoate 3-{3-[(3,5,5-trimethylhexanoyl)oxy]-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propoxy}-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: straw coloured liquid
- Analytical purity: UVCB tested
- Storage condition of test material: at room temperature in darkness

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.71-2.85 kg
- Housing: individual in suspended metal cages.
- Diet: STANRAB SQC Rabbit Diet (Special Diets Services Ltd., Witham, Essex, UK), ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 51-60
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 100%
Duration of treatment / exposure:
4 h
Observation period:
14 days
Reading time points: 1, 24, 48 and 72 h and 7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal flank
- Type of wrap if used: the test material was introduced under a 6.25 cm² cotton gauze patch and held in position with a strip of surgical adhesive tape (BLENDERM: approximately size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed by gentl swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Erythema: 2/3 animals showed slight erythema from 24 h up to 72 h being fully reversible within 7 days. In the remaining animal slight erythema was observed at the 24 and 48 h reading time point only.
Edema: No edema formation was apparent during the study period in any animal.
Other effects:
No other local or systemic effects were reported.

Any other information on results incl. tables

Table 1. Results of skin irritation study.

Observation time

Rabbit number and body weight (kg)

#77

(2.83)

#79

(2.85)

#80

(2.71)

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

0

0

0

0

0

0

24 h

1

0

1

0

1

0

48 h

1

0

1

0

1

0

72 h

1

0

1

0

0

0

7 days

0

0

0

0

0

0

Mean value

24 + 48 + 72 h

1.00

0.00

1.00

0.00

0.67

0.00

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
CLP: not classified

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